Concussion, BrainNCT04099329
One Team: Changing the Culture of Youth Sport With Pregame Safety Huddles
A study testing Pre-game Safety Huddles in people with Concussion, Brain, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Randomized controlled trial of a behavioral intervention (Pre-Game Safety Huddles) designed to study the impact of huddles on concussion safety in youth sport, primarily regarding intention to report concussive symptoms. Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- Pre-game Safety Huddles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participating on a team in one of the recruited leagues and willing to complete surveys
Who cannot join
- Not willing to complete surveys
Trial locations and contacts
1 site in 1 country.
About this study
Randomized controlled trial of a behavioral intervention (Pre-Game Safety Huddles) designed to study the impact of huddles on concussion safety in youth sport, primarily regarding intention to report concussive symptoms.
Read the detailed description
More than 1 million youth sustain a sport-related concussion (SRC) each year. The middle school age range is particularly concerning because it is a time when children have both a unique susceptibility to brain injury and high participation rates in organized sports with concussion risk, such as soccer and football. There are two avenues to decrease concussion risk: (1) minimizing the number and force of collisions to decrease concussion incidence (primary prevention) and (2) improving concussion identification to decrease morbidity (secondary prevention). The goal of this study is to utilize Pre-Game Safety Huddles to discuss sportsmanship (primary prevention) and concussion reporting (secondary prevention) with a goal of improving concussion safety.
To assess the efficacy of Pre-Game Safety Huddles as a tool for injury prevention, we will conduct a Randomized controlled trial with youth sport teams. We will recruit leagues in the Seattle area (girls' soccer, boys' soccer and football) and randomize them to either intervention or control. Coaches in the intervention group will then be trained to lead Pre-Game Safety Huddles before each game over the course of the season (9-12 weeks). Youth and coaches will be surveyed at three time points and data will be analyzed to determine impact of the intervention on two outcomes: 1) expectations regarding reporting concussive symptoms (CR-E) and 2) expectations regarding engaging in potentially injurious play (IP-E).
- Conditions
- Concussion, Brain
- Being tested
- Pre-game Safety Huddles
- Keywords
- Soccer, Football, Injury, Prevention, Concussion, Education, Huddles, Primary prevention, Secondary prevention, Behavioral intervention
- Medical subject headings
- Brain Concussion, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-game Safety HuddlesBehavioural
Coaches will be trained to lead Pre-game Safety Huddles by the RA with the study using a multi-media tool we have developed. Huddles will be brief (1-2 minutes) and will primarily focused on 1) encouraging concussion reporting and 2) encouraging good sportsmanship
| Study group | Role | What they receive |
|---|---|---|
| Pre-game Safety Huddles | Experimental | Pre-game safety huddles will occur before each game and athletes and coaches will be surveyed. Receives: Behavioral: Pre-game Safety Huddles |
| Control | No intervention | No intervention will be delivered by athletes and coaches will be surveyed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change, Expectations regarding concussion reporting (CR-E)
Self-report survey of Athlete expectations regarding reporting concussive symptoms
Measured: Baseline, 4-6 weeks, 9-12 weeks
Secondary outcomes (9)
Change, Expectations of engaging in potentially injurious play (IP-E)
Self-report survey of Athlete rating of expectations of engaging in potentially risky sport behavior
Measured: Baseline, 4-6 weeks, 9-12 weeks
Change, Perceived coach, parent and peer norms regarding concussion reporting (PN-PWCS)
Self-report survey, Athlete perception of norms regarding concussion reporting
Measured: Baseline, 4-6 weeks, 9-12 weeks
Change in Perceived coach (TN-C), parent (TN-P) and peer norms (TN-T) regarding sportsmanship
Self-report survey, Athlete perception of norms regarding sportsmanship
Measured: Baseline, 4-6 weeks, 9-12 weeks
Change, Youth sport values (YSV)
Self-report survey, Athlete values regarding sport participation
Measured: Baseline, 4-6 weeks, 9-12 weeks
Self-report of concussion diagnosis
Athlete report of concussion diagnosis during the season
Measured: 9-12 weeks
Change, Expectations regarding reporting teammate concussion (bystander reporting) (E-BR)
Self-report survey, Athlete intention to report teammate concussive symptoms
Measured: Baseline, 4-6 weeks, 9-12 weeks
Change, Prosocial and Antisocial Behavior in Sport Scale (PABSS)
Self-report survey, Standardized measure of sportsmanship
Measured: Baseline, 4-6 weeks, 9-12 weeks
Performed behavior, concussion reporting (PB--CR)
Self-report survey, Athlete concussion symptoms following potential concussion during season
Measured: 9-12 weeks
Acceptability of Intervention Measure (AIM-2) and Feasibility of Intervention Measure (AIM-2, FIM-2)
Self-report survey, Standardized measures of acceptability and feasibility
Measured: 9-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start24 Aug 2019
- Primary completion1 Jan 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Leagues were randomized to intervention or control
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Southern University, University of Oregon, Northwestern University
- Responsible party
- Principal investigator, Sara PD Chrisman, MD MPH, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099329
- Sponsor's protocol ID
- STUDY00000972
- Status last verified
- Jan 2022
- First submitted
- 7 Aug 2019
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kroshus E, Chrisman SPD, Glang A, Hunt T, Hays R, Lowry S, Peterson A, Garrett K, Ramshaw D, Hafferty K, Kinney E, Manzueta M, Steiner MK, Bollinger BJ, Chiampas G, Rivara FP. Concussion education for youth athletes using Pre-Game Safety Huddles: a cluster-randomised controlled trial. Inj Prev. 2023 Feb;29(1):22-28. doi: 10.1136/ip-2022-044665. Epub 2022 Sep 16.
PubMed 36113984
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Team: Changing the Culture of Youth Sport With Pregame Safety Huddles
- ClinicalTrials.gov ID
- NCT04099329
- Acronym / sponsor ID
- STUDY00000972
- Conditions
- Concussion, Brain
- Keywords
- Soccer, Football, Injury, Prevention, Concussion, Education, Huddles, Primary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Georgia Southern University, University of Oregon, Northwestern University
- Study start
- 24 Aug 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled trial of a behavioral intervention (Pre-Game Safety Huddles) designed to study the impact of huddles on concussion safety in youth sport, primarily regarding intention to report concussive symptoms.
Detailed description
More than 1 million youth sustain a sport-related concussion (SRC) each year. The middle school age range is particularly concerning because it is a time when children have both a unique susceptibility to brain injury and high participation rates in organized sports with concussion risk, such as soccer and football. There are two avenues to decrease concussion risk: (1) minimizing the number and force of collisions to decrease concussion incidence (primary prevention) and (2) improving concussion identification to decrease morbidity (secondary prevention). The goal of this study is to utilize Pre-Game Safety Huddles to discuss sportsmanship (primary prevention) and concussion reporting (secondary prevention) with a goal of improving concussion safety.
To assess the efficacy of Pre-Game Safety Huddles as a tool for injury prevention, we will conduct a Randomized controlled trial with youth sport teams. We will recruit leagues in the Seattle area (girls' soccer, boys' soccer and football) and randomize them to either intervention or control. Coaches in the intervention group will then be trained to lead Pre-Game Safety Huddles before each game over the course of the season (9-12 weeks). Youth and coaches will be surveyed at three time points and data will be analyzed to determine impact of the intervention on two outcomes: 1) expectations regarding reporting concussive symptoms (CR-E) and 2) expectations regarding engaging in potentially injurious play (IP-E).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Leagues were randomized to intervention or control
| Arm | Type | Receives |
|---|---|---|
| Pre-game Safety Huddles | Experimental | Behavioral: Pre-game Safety HuddlesPre-game safety huddles will occur before each game and athletes and coaches will be surveyed. |
| Control | No intervention | –No intervention will be delivered by athletes and coaches will be surveyed. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participating on a team in one of the recruited leagues and willing to complete surveys
Key exclusion criteria (1 listed)
- Not willing to complete surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-game Safety HuddlesCoaches will be trained to lead Pre-game Safety Huddles by the RA with the study using a multi-media tool we have developed. Huddles will be brief (1-2 minutes) and will primarily focused on 1) encouraging concussion reporting and 2) encouraging good sportsmanship | Behavioural | Pre-game Safety Huddles |
Primary outcome
Change, Expectations regarding concussion reporting (CR-E)
Time frame: Baseline, 4-6 weeks, 9-12 weeks
Self-report survey of Athlete expectations regarding reporting concussive symptoms
9 secondary outcomes
Change, Expectations of engaging in potentially injurious play (IP-E)
Time frame: Baseline, 4-6 weeks, 9-12 weeks
Change, Perceived coach, parent and peer norms regarding concussion reporting (PN-PWCS)
Time frame: Baseline, 4-6 weeks, 9-12 weeks
Change in Perceived coach (TN-C), parent (TN-P) and peer norms (TN-T) regarding sportsmanship
Time frame: Baseline, 4-6 weeks, 9-12 weeks
Change, Youth sport values (YSV)
Time frame: Baseline, 4-6 weeks, 9-12 weeks
Self-report of concussion diagnosis
Time frame: 9-12 weeks
Change, Expectations regarding reporting teammate concussion (bystander reporting) (E-BR)
Time frame: Baseline, 4-6 weeks, 9-12 weeks
Change, Prosocial and Antisocial Behavior in Sport Scale (PABSS)
Time frame: Baseline, 4-6 weeks, 9-12 weeks
Performed behavior, concussion reporting (PB--CR)
Time frame: 9-12 weeks
Acceptability of Intervention Measure (AIM-2) and Feasibility of Intervention Measure (AIM-2, FIM-2)
Time frame: 9-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Derived from this study: PubMed 36113984Kroshus E, Chrisman SPD, Glang A, Hunt T, Hays R, Lowry S, Peterson A, Garrett K, Ramshaw D, Hafferty K, Kinney E, Manzueta M, Steiner MK, Bollinger BJ, Chiampas G, Rivara FP. Concussion education for youth athletes using Pre-Game Safety Huddles: a cluster-randomised controlled trial. Inj Prev. 2023 Feb;29(1):22-28. doi: 10.1136/ip-2022-044665. Epub 2022 Sep 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-game Safety Huddles in people with Concussion, Brain, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change, Expectations regarding concussion reporting (CR-E) (time frame: Baseline, 4-6 weeks, 9-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04099329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.